Healthcare Industry News:  Fecal Management System 

Devices Wound Care

 News Release - May 2, 2008

ConvaTec Upgrades Flexi-Seal(R) Fecal Management System to Increase Ease of Use

Innovative System Maintains Skin Condition, Supple and Flexible Design Helps Reduce the Risk of Pressure Ulcers

SKILLMAN, N.J.--(HSMN NewsFeed)--ConvaTec, a world-leading manufacturer of ostomy and wound care products, today announced that its Flexi-Seal® Fecal Management System (FMS), a temporary containment device indicated for immobilized, incontinent patients with liquid or semi-liquid stool, has been redesigned for easier use and storage.

The innovative Flexi-Seal® FMS was designed to safely and effectively divert fecal matter, protect patients’ wounds from fecal contamination, and reduce the risk of both skin breakdown and spread of infection, such as Clostridium difficile (C. difficile).1 The improved Flexi-Seal® FMS retains all of the original product benefits, but also now includes recyclable and re-closeable molded plastic packaging that is 25 percent smaller than the original package size and allows for easy storage of collection bags and syringes; a new blue irrigation port that allows for immediate identification; a re-labeled syringe that is precisely marked to 45 ml and measures the exact amount of water or saline necessary; and a smaller, more user-friendly, pocket-size package insert. The new and improved Flexi-Seal® FMS will be available to medical professionals from the end of April, 2008, at no increase in cost.

“The upgrades to the Flexi-Seal® Fecal Management System were based upon the feedback we received from our customers - critical care nurses who use Flexi-Seal® FMS on a regular basis and provide exceptional care to the patients who benefit from the system,” said Ronald Galovich, Vice President/General Manager, U.S. Wound Therapeutics. “Interest in Flexi-Seal® FMS has continued to expand since its introduction, particularly in light of the increased focus on pressure ulcer prevention under the new Medicare rules, and the ongoing focus on infection control in general.”

About Fecal Incontinence and Pressure Ulcers

The management of fecal incontinence, a significant risk factor in the development of pressure ulcers and the transmission of nosocomial infections, is a priority in acute and critical care hospital settings. Findings from a model incorporating retrospective data indicated that the odds of having a pressure ulcer were 22 times greater for hospitalized adult patients with fecal incontinence, compared to those who were continent.2 Pressure ulcers, which are among the most prevalent forms of chronic wounds, are reported in approximately 10-18 percent of acute-care settings in the United States,3 and can increase both patient mortality rates and the cost of patient care.4 By October, 2008, the U.S. Centers for Medicare and Medicaid Services (CMS) will institute reimbursement reforms for hospital-acquired pressure ulcers, prompting many U.S. hospitals to implement pressure ulcer prevention guidelines and utilize systems and devices that can help prevent pressure ulcer development.5

About Flexi-Seal® Fecal Management System

Flexi-Seal® FMS is a temporary containment device indicated for patients with little or no bowel control, and can be used for up to 29 consecutive days. Unique features of Flexi-Seal® FMS include:
  • A closed-end collection bag which may help reduce the spread of infection.
  • A soft, low-pressure balloon designed to minimize the chance of tissue necrosis.
  • A soft, flexible silicone catheter that can collapse to an 8 mm diameter after insertion and conform to sphincter tone and anatomy.
  • An entirely latex-free design.
A prospective, phase II, open-label, non-randomized clinical study involving 42 patients from seven U.S. hospitals was performed to evaluate the safety of Flexi-Seal® FMS.1 The study found that Flexi-Seal® FMS maintained or improved skin condition in 92 percent of patients, and that use of the device revealed no adverse effect on rectal mucosa. Most patients were able to retain the device until removal. Caregivers from both the intensive care units and acute care units reported that Flexi-Seal® FMS improved control of fecal incontinence with minimal leakage, and was practical, efficacious, time-efficient, and both caregiver and patient-friendly. Four subjects experienced non-serious adverse events. One subject, who had a history of gastrointestinal (GI) bleeding, developed a lower GI bleed with ulceration four days after placement of the device, and was discontinued from the study. The event was considered to be related to the use of the device. Five subjects expired during the study, and all deaths were determined to be unrelated to the device.

To date, Flexi-Seal® FMS is the number one brand6 in unit sales to distributors, and is being widely used at over 1,800 intensive care unit hospitals7 in the United States.

About ConvaTec

ConvaTec, a world-leading manufacturer of ostomy and wound care products, is at the forefront of the movement to change the way health care professionals are managing chronic and acute wounds. Since the introduction of DuoDERM® Hydroactive Dressing in 1982, ConvaTec has been a pioneer in the establishment of moist wound healing. Today, ConvaTec is building on this strong heritage with its Hydrofiber® technology, featured in advanced wound dressings such as AQUACEL® Ag, an absorbent, soft, conformable, antimicrobial dressing with ionic silver, which forms a cool gelling sheet on contact with exudate. ConvaTec is a Bristol-Myers Squibb Company (NYSE:BMY ), a global pharmaceutical and related health care products company. For more information, please call 800-422-8811 or visit

Flexi-Seal, DuoDERM, Hydrofiber and AQUACEL are registered trademarks of E.R. Squibb & Sons, L.L.C.

© 2008 E.R. Squibb & Sons, L.L.C.


1. Padmanabhan A., Stern M., Wishin J., Mangino M., Richey K., DeSane M. Clinical evaluation of a flexible fecal incontinence management system. American Journal of Critical Care, July 2007; Volume 16, No. 4.

2. Maklebust J, Magnan MA. Risk factors associated with having a pressure ulcer: a secondary data analysis. Adv Wound Care. 1994 Nov; 7(6):25, 27-8, 31-4 passim.

3. Pressure ulcers in America: prevalence, incidence and implications for the future. An executive summary of the National Pressure Ulcer Advisory Panel monograph. Advances in Skin and Wound Care 2001; 14:208-15.

4. Wishin J, Gallagher TJ, McCann E. Emerging options for the management of fecal incontinence in hospitalized patients. J Wound Ostomy Continence Nurs. 2008;35(1):104-110.

5. Centers for Medicare and Medicaid Services, Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2008 Rates: Final Rule, 72 Federal Register 62 (August 22, 2007), 47201-47206.

6. HPIS. Q4 2007 data. Moving Annual Total (MAT) Fecal Control Category. Data on file, ConvaTec.

7. ConvaTec Redistributed YTD Sales through February 2008. Data on file, ConvaTec.

Source: ConvaTec

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.

FindReps - Find Great Medical Independent Sales Reps without recruiter fees.
FindReps - available on the Apple App Store for iPhone and iPad.